> ## Documentation Index
> Fetch the complete documentation index at: https://docs.carelane.io/llms.txt
> Use this file to discover all available pages before exploring further.

# CRF Signing

> Electronic signature workflows for case report forms

CRF signing provides an electronic signature workflow for finalizing completed case report forms. When enabled, authorized signers review and sign completed records.

## Signing Overview

The signing process ensures:

* Data has been reviewed before finalization
* An authorized person approves the record
* Signature is captured and recorded
* Audit trail documents the sign-off

## Enabling CRF Signing

Configure signing requirements at the study level:

<Steps>
  <Step title="Navigate to Study Settings">
    Go to Study Settings > Participant Settings.
  </Step>

  <Step title="Enable CRF Signing">
    Toggle "CRF Sign-off Required" to enabled.
  </Step>

  <Step title="Save">
    Save the settings. Signing workflow becomes active.
  </Step>
</Steps>

<Note>
  Enabling signing affects the record workflow. Records will require signature after verification to reach final status.
</Note>

## Record Workflow with Signing

When signing is enabled:

```
In Progress → Completed (Site) → Verified (Study Team) → Signed (Site)
```

Records must be verified by the study team before they can be signed by the site.

## Authorized Signers

Only users with the **Authorized Signer** role can sign CRFs:

### Who Can Sign

| Role                        | Can Sign                        |
| --------------------------- | ------------------------------- |
| Primary Investigator        | Yes (if also Authorized Signer) |
| Deputy Primary Investigator | Yes (if also Authorized Signer) |
| Authorized Signer           | Yes                             |
| Other Roles                 | No                              |

### Assigning Authorized Signer Role

<Steps>
  <Step title="Navigate to Site Team">
    Open Site > Team.
  </Step>

  <Step title="Add Role">
    Add the "Authorized Signer" role to appropriate team members.
  </Step>
</Steps>

<Tip>
  The Authorized Signer role is typically assigned in addition to another role (e.g., PI + Authorized Signer).
</Tip>

## Signing Process

<Steps>
  <Step title="Identify Records to Sign">
    Navigate to participant records with "Verified" status.
  </Step>

  <Step title="Review Record">
    Review the data in the questionnaire.
  </Step>

  <Step title="Click Sign CRF">
    Click **Sign CRF** to open the **Confirm Your Identity** dialog.
  </Step>

  <Step title="Re-Authenticate">
    The dialog displays **Signing as \[Your Name]** and asks you to re-enter your Carelane password. If your account has MFA enabled, you also complete the MFA challenge here.
  </Step>

  <Step title="Apply Signature">
    On successful re-authentication, the signature is applied and the record transitions to **Signed**.
  </Step>
</Steps>

### Credentialed Signature

Signing requires the signer to re-authenticate, even though they are already logged in. This aligns the signature flow with 21 CFR Part 11 expectations for credentialed, non-repudiable electronic signatures.

The signature record captures:

* **Signer identity** — the authenticated user ID and display name
* **Timestamp** — when the signature was applied
* **Jurisdiction** — where the signature is made
* **Optional signature image**

<Note>
  If your Carelane password is wrong or your MFA code fails, the signature is not applied and the record remains in **Verified** status. You can retry immediately.
</Note>

## Signature Requirements

### Prerequisites for Signing

Records can only be signed when:

* Status is "Verified (Study Team)"
* No open queries exist
* All required fields are complete
* The user has Authorized Signer role

### Signature Meaning

The signature attests that:

* The data has been reviewed
* The data is accurate to the best of the signer's knowledge
* The signer takes responsibility for the record

## Viewing Signatures

Access signature information:

<Accordion title="Signature Details">
  On a signed record, view signature details including:

  * Who signed
  * When they signed
  * Jurisdiction
  * Signature image (if captured)
</Accordion>

## Bulk Signing

For efficiency, sign multiple records:

<Steps>
  <Step title="Select Records">
    From the participant list, filter for signable records.
  </Step>

  <Step title="Review Each">
    Review records before signing.
  </Step>

  <Step title="Bulk Sign">
    Select multiple records and apply signature.
  </Step>
</Steps>

<Warning>
  Even with bulk signing, ensure each record has been reviewed. The signature indicates you have reviewed the data.
</Warning>

## Signature Audit Trail

All signatures are recorded in the audit trail:

* Signature event timestamp
* Signer identification
* Signature metadata
* Any subsequent changes (which void the signature)

## Amending Signed Records

If changes are needed after signing:

1. Data changes reset the signature status
2. Record returns to "Verified" status
3. New signature is required
4. Audit trail shows the change history

## Best Practices

<AccordionGroup>
  <Accordion title="Review Before Signing">
    Always review data before signing, even for bulk operations.
  </Accordion>

  <Accordion title="Timely Signing">
    Sign records promptly after verification to maintain workflow efficiency.
  </Accordion>

  <Accordion title="Limit Authorized Signers">
    Only assign Authorized Signer to personnel with appropriate authority.
  </Accordion>

  <Accordion title="Document Delegation">
    Maintain documentation for signing authority delegation per regulatory requirements.
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Site Roles" icon="shield" href="/roles-permissions/site-roles">
    Authorized Signer role details.
  </Card>

  <Card title="Participant Records" icon="file-medical" href="/participants/participant-records">
    Record workflow and status.
  </Card>
</CardGroup>